Xibrom (bromfenac sodium ophthalmic solution) 0.09% (ISTA Pharmaceuticals, Inc.) achieved the primary endpoint of its Phase III trial: absence of ocular inflammation 15 days postoperatively.
Xibrom (bromfenac sodium ophthalmic solution) 0.09% (ISTA Pharmaceuticals, Inc.) has achieved the primary endpoint of its Phase III trial: absence of ocular inflammation 15 days postoperatively.
In two multicentre, randomized, double-masked trials, 282 patients undergoing cataract surgery were dosed with either Xibrom or placebo once daily for one day before and 14 days following surgery.
In addition to achieving its primary endpoint, Xibrom also met the secondary endpoint of the trial: eradication of ocular pain at one day postoperatively. These results were cumulative: one of the trial arms showed statistical significance in achievement of both primary and secondary endpoints, while the second arm did not achieve statistical significance in either. In this second arm, there was a higher percentage of discontinuation due to lack of efficacy, and a greater reported response to placebo. There were no significant ocular or systemic adverse events in either trial arm, and an overall trend of decrease in photophobia was witnessed.
ISTA now plans to perform a further Phase III trial, which the company expects to conclude next year.